Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers
NCT ID: NCT01156246
Last Updated: 2012-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2010-06-30
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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1
Dapagliflozin/metformin tablet, high fat, high calorie breakfast day 1, visit 2, 7-14 days wash-out, Dapagliflozin/metformin tablet, fasting conditions day 1, visit 3.
Dapagliflozin/Metformin
oral fixed dose combination tablet 5 mg Dapagliflozin / 1000 mg Metformin given on day 1 at visit 2 and 3.
2
Dapagliflozin/metformin tablet, fasting conditions day 1, visit 2, 7-14 days wash-out, Dapagliflozin/metformin tablet, high fat, high calorie breakfast day 1, visit 3.
Dapagliflozin/Metformin
oral fixed dose combination tablet 5 mg Dapagliflozin / 1000 mg Metformin given on day 1 at visit 2 and 3.
Interventions
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Dapagliflozin/Metformin
oral fixed dose combination tablet 5 mg Dapagliflozin / 1000 mg Metformin given on day 1 at visit 2 and 3.
Eligibility Criteria
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Inclusion Criteria
* BMI 18-30 kg/m2
Exclusion Criteria
* History of alcohol or drug abuse
18 Years
55 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Aslak Rautio
Role: PRINCIPAL_INVESTIGATOR
Quintiles Hermelinen AB, Varvsgatan 53, SE-972 33 Luleå, Sweden
Wolfgang Kühn
Role: PRINCIPAL_INVESTIGATOR
Quintiles AB, Global Phase I Services, Strandbodgatan 1, SE-753 23 Uppsala, Sweden
Mirjana Kujacic
Role: STUDY_CHAIR
AZ Global Clinical Development, Pepparedsleden 1, 431 83 Mölndal, 431 83 Mölndal
Locations
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Research Site
Luleå, , Sweden
Countries
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Other Identifiers
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D1691C00005
Identifier Type: -
Identifier Source: org_study_id
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